FDA Adverse Event
Injury
Summary report: N
5.0MM SELF -DRILLING SCHANZ SCREW 60MM THRD/175MM
MDR report key: 1002551
·
Received February 26, 2008
Report
- Report Number
- 1719045-2008-00014
- Event Type
- Injury
- Date Received
- February 26, 2008
- Date of Event
- December 2, 2007
- Report Date
- January 29, 2008
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HWC
- PMA / PMN Number
- K952296
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE MFG DATE WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
TIBIAL EXTERNAL FIXATOR SCHANZ SCREWS HEATED DURING MRI. SOFT TISSUE BURNS WERE NOTED. DURING PLANNED REMOVAL OF EXTERNAL FIXATOR FOR ORIF TIBIA, SURGEON NOTED INFECTION AND PACKED AREA WITH ANTIBIOTIC BEADS. AT REVISION SURGERY, THE ANTIBIOTIC BEADS WERE REMOVED, BONE GRAFT WAS PLACED, AND SOFT TISSUE BURNS WERE DEBRIDED DUE TO SIGNS OF INFECTION. SURGEON WILL CONTINUE TO MONITOR PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5.0MM SELF -DRILLING SCHANZ SCREW 60MM THRD/175MM | SCHANZ SCREWS | HWC | SYNTHES MONUMENT | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR | Required Intervention | CLAMPS| RODS| EXTERNAL FIXATOR |